Compounding Pharmacies Will Be Subject to FDA Oversight

Congress has enacted legislation to regulate compounding pharmacies. Just over a year ago many cases of fungal meningitis alarmed public health authorities around the country. Most cases were linked to spinal injections of contaminated steroid medicines produced by the New England Compounding Center. Eventually, 64 people died and over 700 required treatment.

Compounding pharmacies in other states were also found to be turning out contaminated products. Over the last year there have been drug recalls from nearly two dozen compounding pharmacies.

Now Congress has passed a new bill that gives the FDA authority to inspect high-volume compounding facilities. This is a voluntary process, however, so only pharmacies that register with the FDA will be subjected to inspections. There is hope that hospitals, clinics and doctors’ offices will only order medications from FDA-inspected facilities and thereby improve the overall manufacturing standards of such products.

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2 Thoughts Shared

PP

November 30, 2013 at 8:07 pm

Considering how lax the FDA is on other things, don’t expect too much–but the state health departments should also be getting into this problem. The other side of it is that big pharma would like to close down even small scale competitors to their high priced potions! I’m thankful for a local compounder who sells me a drug that is $30 less than the COPAY for a pharmacy drug!

Donnie

November 29, 2013 at 10:13 am

The FDA should be given the authority to inspect all of those pharmacies, and close down the ones who are filthy, or making contaminated drugs and products. The FDA is supposed to be working for the benefit of the people, not allowing the drug and medical device industries to harm us with their shoddy or unsafe products. Our government agencies should never pander to corporations, at the expense of our health and safety.

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